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Effect of Raltegravir in Patients With Acute Tropical Spastic Paraparesis - Human T-Lymphotropic Virus 1 Infection

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ClinicalTrials.gov Identifier: NCT02655471
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Universidad Peruana Cayetano Heredia

Brief Summary:
This is a pilot study of intervention in a group of patients with tropical spastic paraparesis/ myelopathy to evaluate virologic and clinical response of raltegravir plus zidovudine in this group of patients.

Condition or disease Intervention/treatment Phase
HTLV-I Infections Tropical Spastic Paraparesis Drug: "Raltegravir" and "Zidovudine" Early Phase 1

Detailed Description:

The study will the investigators develop in The Tropical Medicine Institute Alexander von Humboldt that is a referral center in Peru for diseases associated to Human T-Lymphotropic Virus 1 Infection (HTLV-1). The Institute has a cohort of around 600 patients currently being followed up and around 20 to 25 new patients are admitted every year with this disease.

This is a pilot study of intervention in a group of patients with tropical spastic paraparesis/ myelopathy to evaluate virologic and clinical response of raltegravir plus zidovudine in this group of patients on the follow-up of 48 weeks.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Raltegravir in Patients With Myelopathy/Tropical Spastic Paraparesis Associated With Infection by Human T-Lymphotropic Virus 1 (HTLV-1). Pilot Study
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : March 15, 2019
Actual Study Completion Date : March 15, 2019


Arm Intervention/treatment
Experimental: HTLV-1 plus Tropical Spastic paraparesis
Patients with recent onset of Tropical Spastic paraparesis due HTLV-1 will receive combination of "Raltegravir" and "Zidovudine" during 48 weeks
Drug: "Raltegravir" and "Zidovudine"
Through measure of pro-viral load and clinical score, we evaluate about safety and efficacy of combination of Raltegravir 400 mg BID and zidovudine 300 mg BID in patients with recent onset of Tropical Spastic paraparesis due HTLV-1 during 48 weeks
Other Names:
  • "Raltegravir"
  • "Zidovudine"




Primary Outcome Measures :
  1. Measure of proviral load [ Time Frame: 48 weeks ]
    Evaluate the effect of raltegravir on proviral load , measured as copies/1000 PBMC, in patients with myelopathy of recent onset associated to HTLV-1 at 48 weeks.


Secondary Outcome Measures :
  1. Measure of Disability Scale [ Time Frame: 48 weeks ]
    Evaluate the effect of raltegravir on Kurtzke Expanded Disability Status Scale in patients with myelopathy of recent onset associated to HTLV-1 at 48 weeks.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • human t lymphotrophic virus 1 confirmed
  • Tropical Spastic Paraparesis of recent onset (less than 4 years)

Exclusion Criteria:

  • Pregnant or breastfeeding or unwilling to use contraception.
  • Treatment with immunosuppressive, immunomodulatory or experimental treatments within the last 6 months of enrolment in the study.
  • Patients presenting with medical disorder such as poorly controlled diabetes or arterial hypertension, severe cardiac insufficiency, unstable ischemic heart disease, abnormal liver function tests (>2.5 times upper limit normal (ULN)) and abnormal complete blood count (in particular leukopenia, as defined by a lymphocyte count <500, neutrophil <1.5 or platelet count < 100, or thrombocytopenia < 1.5 low limit normal (LLN), or any medical condition which, in the opinion of the chief investigator, would pose additional risk to the patient.
  • Presence of human immunodeficiency virus antibodies.
  • Patients with active hepatitis B or/and C with liver function tests >2.5 times ULN
  • Exposure to any other investigational drug within 30 days of enrolment in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655471


Locations
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Peru
Instituto de Medicina Tropical Alexander von Humboldt
Lima, Peru, 01
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Eduardo Gotuzzo, MD Instituto de Medicina Tropical Alexander von Humboldt
Principal Investigator: Fernando Mejía, MD Instituto de Medicina Tropical Alexander von Humboldt

Publications of Results:

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Responsible Party: Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT02655471     History of Changes
Other Study ID Numbers: 65384
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Muscle Spasticity
Paraparesis
Paraparesis, Spastic
Paraparesis, Tropical Spastic
HTLV-I Infections
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Paresis
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Zidovudine
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents